Mobile Monitor Cart System MMCS A0093

GUDID 19120075320105

Mobile Monitor Cart System "MMCS": The Mobile Monitor Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Mobile Monitor Cart System can be used to move medical equipment (e.g. the IRm control unit) within the building or to position it in the room. If the system is used in conjunction with the IRm operating unit, the mobile monitor cart system expands the display and control options of the mobile X-ray imaging system "ImagingRing m" or "Loop-X®" (abbreviated Rm) of medPhoton GmbH. The mobile monitor cart system is listed and released as an accessory and included in the technical documentation and 510(k) premarket submissions for the ImagingRing m. Therefore it is also registered under the same listing number and product code.

medPhoton GmbH

Image display unit, colour

• Primary Device ID: 19120075320105
• NIH Device Record Key: 88612ff6-50ab-477f-bd6f-ed5813ad5b1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mobile Monitor Cart System MMCS
• Version Model Number: 1
• Catalog Number: A0093
• Company DUNS: 300376801
• Company Name: medPhoton GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19120075320105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203281

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-18
• Device Publish Date: 2025-06-10

Devices Manufactured by medPhoton GmbH

• 19120075320105 - Mobile Monitor Cart System MMCS: 2025-06-18Mobile Monitor Cart System "MMCS": The Mobile Monitor Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Mobile Monitor Cart System can be used to move medical equipment (e.g. the IRm control unit) within the building or to position it in the room. If the system is used in conjunction with the IRm operating unit, the mobile monitor cart system expands the display and control options of the mobile X-ray imaging system "ImagingRing m" or "Loop-X®" (abbreviated Rm) of medPhoton GmbH. The mobile monitor cart system is listed and released as an accessory and included in the technical documentation and 510(k) premarket submissions for the ImagingRing m. Therefore it is also registered under the same listing number and product code.
• 19120075320105 - Mobile Monitor Cart System MMCS: 2025-06-18 Mobile Monitor Cart System "MMCS": The Mobile Monitor Cart System (including the components mounted on it) is intended for use i
• 19120075320136 - Remote Control Charging Cart RCCS: 2025-06-18 Remote Control Charging Cart "RCCS": The Remote Control Charging Cart System (including the components mounted on it) is intende
• 19120075320112 - ImagingRing m: 2025-06-05 ImagingRing m, Version 2: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluorosc
• 19120075320129 - Loop-X: 2025-06-05 Loop-X Mobile Imaging Robot: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluor
• 19120075320068 - ImagingRing m: 2021-03-30 Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to a
• 19120075320075 - Loop-X: 2021-03-30 Loop-X Mobile Imaging Robot: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluor
• 19120075320013 - ImagingRing: 2019-04-23
• 19120075320037 - ImagingRing: 2019-04-23